FDAFDA · Food and drugs·Recall number Z-0442-2014
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Published December 11, 2013 · Recall initiated: November 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.
- Lot
- UPN M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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